Class III · Low risk
Benzphetamine Hydrochloride Tablets
Discoloration: presence of scuffing marks on tablets.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Dicloxacillin Sodium Capsules USP
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Dicloxacillin Sodium Capsules
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Hectorol (doxercalciferol injection)
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class III · Low risk
CVS pharmacy Original Strength Acid Controller tablets
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Class III · Low risk
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class III · Low risk
SKY Aspirin Chewable Tablets
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Lisinopril & Hydrochlorothiazide Tables
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
¿Topicort (desoximetasone)
Subpotent Drug
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Intermezzo
Failed Dissolution Specifications
Class III · Low risk
Venlafaxine 75 mg Tablet
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Class III · Low risk
Escitalopram Tablets USP 20 mg
Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk
Zemplar (paricalcitol)
Failed Content Uniformity Specifications
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date